Status:
RECRUITING
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Collaborating Sponsors:
Libbs Farmacêutica LTDA
Conditions:
Acute Lymphoblastic Leukemia, in Relapse
Acute Lymphoblastic Leukemia With Failed Remission
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), see...
Detailed Description
Acute lymphoblastic leukemia (ALL) is a rare neoplasm in adults, with long-term survival rates approaching 50% with current regimens. Although high rates of complete response are achieved with the fir...
Eligibility Criteria
Inclusion
- Patients between 16 and 60 years-old with refractory or relapsed ALL (≥1% of anomalous blasts by flow cytometry in bone marrow or peripheral blood) after one or two lines of therapy, regardless of their phenotype or baseline genetic alteration;
- Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD).
Exclusion
- Burkitt leukemia;
- Prior myeloproliferative disease;
- Drug allergies;
- Eastern Cooperative Oncology Group (ECOG) scale \>2;
- Total bilirubin\>2x upper limit of normal (ULN);
- Transaminases\>5x ULN;
- Creatinine\>2,5 mg/dl;
- Active uncontrolled infection;
- History of asparaginase-induced pancreatitis;
- Prior exposure to bortezomib;
- Heart failure New York Heart Association (NYHA) Class III or IV;
- Patients with more than 400mg/m2 lifetime exposure of anthracycline;
- Severe psychiatric disorder which prevents adequate compliance;
- Refusal to participate in the study.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06034561
Start Date
April 1 2024
End Date
August 1 2029
Last Update
May 16 2025
Active Locations (1)
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1
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil, 01246000